Teva Olanzapine Tablet 5 mg

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Increases above the usual recommended daily dose of 10 mg are recommended only after an appropriate clinical assessment. 1) Schizophrenia The initial recommended dose is 5∼10 mg of olanzapine once daily. Maintenance treatment: Although there is no clear answer as to how long treatment with this medicine should continue, its efficacy was demonstrated in a placebo-controlled study in patients with schizophrenia whose symptoms had stabilized after taking this medicine for approximately 8 weeks and who received maintenance treatment at doses of 10∼20 mg daily for 8 months. The need for maintenance treatment at an appropriate dose should be assessed periodically. 2) Bipolar disorder Treatment of manic and mixed episodes associated with bipolar I disorder The initial dose is 15 mg of this medicine once daily as monotherapy, or 10 mg once daily as adjunctive therapy with lithium or valproate. Prevention of recurrence in bipolar disorder The initial recommended dose is 10 mg once daily. Patients who have been receiving this medicine to treat mania should continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, treatment with this medicine should continue, along with adjunctive therapy to treat mood symptoms according to clinical indications (optimizing the required doses as needed). 3) For the treatment of schizophrenia and manic and mixed episodes associated with bipolar I disorder, and prevention of recurrence in bipolar disorder, the daily dose may be adjusted within the range of 5 mg to 20 mg daily based on clinical condition. Increases above the initial recommended dose are recommended only after an appropriate clinical assessment, and the dose should generally be increased at intervals of 24 hours or more. If treatment with this medicine is discontinued, the dose should be reduced gradually and cautiously. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5mg of olanzapine once daily and increase to 10mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms; the daily dose should not exceed 20mg. Since food does not affect drug absorption, this medicine may be taken with or without food. Elderly patients Starting at a dose of 5 mg or less daily may be considered when there is sufficient evidence based on clinical factors. Patients with renal or hepatic impairment A low initial dose (5 mg) should be considered. In moderate hepatic impairment (cirrhosis, Child-Pugh class A or B), the initial dose is 5 mg, and the dose should be increased cautiously. Patients with multiple factors that delay the metabolism of this medicine (female sex, older age, nonsmoking status) may also be started at a lower dose.

This medication may cause serious side effects, including neuroleptic malignant syndrome, which can be life-threatening, so treatment should be discontinued immediately if unusual high fever, muscle rigidity, or changes in mental state arise. It is advisable not to use this drug for the treatment of psychosis or behavioral disturbances associated with dementia, especially in elderly patients, as there may be an increased risk of mortality and cerebrovascular accidents. Prolonged use may lead to movement disorders known as tardive dyskinesia; if symptoms occur, consideration should be given to dosage adjustment or discontinuation. During the initial treatment phase, it may take time for the effects to manifest, so the patient's condition should be carefully monitored. Because it can affect blood sugar control, diabetic patients or those with risk factors should regularly monitor their blood sugar and weight and consult a doctor if unusual symptoms arise. Sudden discontinuation of this medication may lead to symptoms such as sweating, insomnia, and anxiety, so gradually reducing the dosage is safer. Patients with cardiovascular disease, the elderly, or patients with impaired liver function should use this medication cautiously, particularly those with hypotension, bradycardia, or cardiac abnormalities. Women who are pregnant or breastfeeding should consult their doctor before use as it may affect the fetus or newborn. There may be interactions with other medications, so any current medications should be disclosed, particularly avoiding concurrent use with epinephrine. This drug may cause drowsiness and dizziness; caution should be exercised when driving or operating hazardous machinery. In case of overdose, serious side effects may occur, so it is essential to adhere strictly to the recommended doses and immediately notify medical personnel of any unusual symptoms. This medication should be kept out of the reach of children, protected from direct sunlight and moisture, and stored at an appropriate temperature.

Hyperthermia, muscle rigidity, altered mental status, irregular pulse, unstable blood pressure, tachycardia, sweating, cardiac arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute renal failure, increased mortality, cerebrovascular adverse reactions, stroke, transient ischemic attack, tardive dyskinesia, drowsiness, weight gain, eosinophilia, elevated prolactin, increased cholesterol, elevated blood glucose, elevated triglycerides, diabetes, increased appetite, akathisia, Parkinsonism, leukopenia, neutropenia, movement disorders, orthostatic hypotension, anticholinergic effects, elevated liver transaminases, rash, asthenia, fatigue, fever, arthralgia, increased alkaline phosphatase, elevated gamma-glutamyl transferase, increased uric acid, elevated creatine kinase, edema, acidosis, increased alkaline phosphatase, bilirubinemia, dehydration, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, lower extremity edema, upper extremity edema, hyperkalemia, ketoacidosis, coma, gout, hypernatremia, hypoproteinemia, ketosis, water intoxication, hypothermia, dizziness, insomnia, depression, lightheadedness, Parkinsonism, all extrapyramidal symptoms, personality disorder, tremor, hypertonicity, dysarthria, sensory disturbances, apathy, confusion, unusual euphoria, coordination disorders, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenia reactions, akinesia, alcohol abuse, antisocial reactions, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, nonsensical speech, dementia, depersonalization, stuttering, facial paralysis, sensory loss, reduced mobility, decreased muscle tone, decreased libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, confusion, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempts, amnesia, seizures, dystonia, restless legs syndrome, paralysis around the mouth, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid hemorrhage, tobacco abuse, neuroleptic malignant syndrome, withdrawal symptoms, orthostatic hypotension, tachycardia, hypertension, hypotension, syncope, bradycardia, atrial fibrillation, cerebrovascular accident, congestive heart failure, cardiac arrest, hemorrhage, migraine, pallor, palpitations, vasodilation, ventricular ectopic beats, QTc prolongation, thrombosis, arteritis, heart failure, pulmonary embolism, ventricular fibrillation, sudden death, diabetes mellitus, diabetic ketoacidosis, goiter, constipation, thirst, dyspepsia, vomiting, increased salivation, dysphagia, esophagitis, fecal incontinence, gastritis, gastroenteritis, gingivitis, black stools, oral ulcers, nausea, oral candidiasis, periodontal abscess, rectal bleeding, stomatitis, tongue swelling, dental caries, diarrhea, abdominal bloating, excessive salivation, aphthous stomatitis, enteritis, belching, esophageal ulcer, glossitis, intestinal obstruction, bowel obstruction, discoloration of the tongue, pancreatitis, rhinitis, increased cough, pharyngitis, dyspnea, apnea, asthma, epistaxis, hemoptysis, hyperventilation, hypoxia, laryngitis, voice changes, atelectasis, hiccups, respiratory depression, pulmonary edema, stridor, hepatic steatosis, hepatitis, jaundice, sweating, photosensitivity reaction, acne, skin dryness, alopecia, contact dermatitis, eczema, papular rash, itching, seborrhea, skin discoloration, skin ulcers, urticaria, vesicular rash, hirsutism, pustular rash, drug reactions, back pain, chest pain, toothache, flu-like syndrome, injection site pain, abdominal enlargement, chills, facial swelling, self-harm, lethargy, candidiasis, neck pain, neck stiffness, pelvic pain, hangover, sudden death, joint stiffness, single contraction, arthritis, arthrosis, leg cramps, myasthenia gravis, arthralgia, bone pain, bursitis, myopathy, osteoporosis, rheumatoid arthritis, rhabdomyolysis, amblyopia, visual disturbances, conjunctivitis, abnormal accommodation, blepharitis, cataract, hearing loss, diplopia, dry eyes, ear pain, ocular hemorrhage, retinitis, eye pain, extraocular muscle abnormalities, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, decreased macular pigmentation, miosis, mydriasis, pigmentation of the lens, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, breast pain, cystitis, reduced menstruation, urinary obstruction, galactorrhea, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, frequent urination, urinary retention, oliguria, uterine fibroid hypertrophy, vaginal bleeding, urinary delay, albuminuria, breast enlargement, mastitis, reduced urine output, male erectile dysfunction, benign decreased libido, female amenorrhea, hypergalactorrhea, breast enlargement, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine kinase, elevated gamma-glutamyl transferase, increased uric acid, total bilirubin elevation, neonatal withdrawal syndrome, ocular motor seizures, confusion, takeistic muscle spasms, oculomotor nerve paralysis, headache, abdominal pain, pain, weight loss, bloody stool, cramps, hypomania, sexual discomfort, neuroexcitability reactions, auditory hallucinations, liver failure, decreased appetite, urinary obstruction, pyelonephritis, abnormal ECG, pupillary atony, torticollis, tachycardia, excitation, aggression, stuttering, various extrapyramidal symptoms, decreased consciousness level, nonsensical speech, seizures, respiratory function inhibition, aspiration, hypertension, hypotension, arrhythmia, cardiopulmonary arrest

This medication should be stored in a sealed container to prevent air ingress and kept in a cool place between 15 and 30 degrees Celsius. Storing it this way can help maintain the drug's effectiveness.

Appearance

White, round, biconvex, film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)